Safety Study About the mRNA Vaccines Against COVID-19 in Children (PEDIVACOV-HCSC)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-08

Study Completion Date

2023-03-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Drugs side effects in children need to be evaluated in a different way because of their constant growth and body changes.

The use of COVID-19 vaccines (mRNA vaccines) is worldwide spread as a safety measure against the pandemic.

Although clinical trials have shown that vaccines are safe in the general population, specific real-life monitoring is needed to address the special situation that applies to children.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Determining Reactogenicity and Immunogenicity of Delayed COVID-19 Vaccine Schedule in Children

NCT05329064

Vaccine Reaction COVID-19 Children, Only

UNKNOWN PHASE4

Safety of Pediatric COVID-19 Vaccination

NCT05157191

Pain Injection Site Reaction Adverse Drug Event

COMPLETED

A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age

NCT04796896

SARS-CoV-2

COMPLETED PHASE2/PHASE3

Study to Evaluate Safety and Immunogenicity of COVID-19 Vaccine in Children 6 Months to < 12 Years

NCT05468736

COVID-19

ACTIVE_NOT_RECRUITING PHASE2/PHASE3

A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine Among Children in Brazil

NCT05403307

COVID-19

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Drug-related side effects are an important health problem causing an increase in health costs. Most of the related research is focused on the adult population, therefore evidence in pediatric patients is scarse. This situation remains true in the clinical trials of the mRNA vaccines against COVID-19, with most studies suggesting the need of a greater follow up and specific research that address the pediatric population. Even though vaccines seem to be a safe and effective ways to protect the population against the COVID-19 pandemic, more information is needed regarding the safety profile for pediatrics in the short and long term.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 Vaccine Adverse Reaction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vaccinated children

Children between 5 and 12 years old vaccinated with 2 doses of an approved mRNA vaccione against COVID-19.

mRNA COVID-19 vaccine

Intervention Type BIOLOGICAL

Children will be vaccinated according to standard local procedure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

mRNA COVID-19 vaccine

Children will be vaccinated according to standard local procedure

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients of both sexes between 5 and 12 years old.
* Pediatric patients with data included in the Clinico San Carlos' Hospital available for consultation.
* Acceptance by the parents/legal guardians for the participation and follow up.